Kornimate/medical-research-clean huggingface dataset:
study to evaluate the bioequivalence of astellas phama korea inc. "harnal-d" in healthy volunteers

Conditions: Benign Prostatic Hyperplasia

Summary: this study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of chong kun dang pharmaceutical "chong kun dang tamsulosin hcl tablet" and astellas phama korea inc. "harnal-d" in healthy volunteers

to healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week. reference drug: harnal-d tab. / test drug: chong kun dang tamsulosin hcl tab. pharmacokinetic blood samples are collected up to 48hrs. the pharmacokinetic characteristics and safety are assessed.

Eligibility criteria:
inclusion criteria: 1. healthy subject older than 19 years men at the screening 2. individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, eeg, ecg, chest x-ray, endoscope or upper gastrointestinal radiography) 3. individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ecg etc.) 4. individuals who had 18 kg/m2 ≤ body mass index(bmi) ≤ 30kg/m2 \* bmi = weight(kg)/ height(m)2 5. individuals who had agreed to participate in the study 6. individuals without mental illness history within five year prior to the screening 7. individuals without a medical history of gastrointestinal operations that may affect drug absorption 8. individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration exclusion criteria: 1. individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month 2. individuals who had excessive drinking within the 1 month \*men: 21 glasses/week exceeded(1 glass: distilled spirits 45 ml, wine 150 ml, beer 360 ml) 3. individuals who had taken any medication within 10 days prior to the first day of dosing 4. individuals who were deemed to be inappropriate to participate in the study by the investigator 5. individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing 6. individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s) 7. individuals with hypersensitivity (include vascular edema) to ingredients used in the investigational product(s) 8. individuals with hereditary diseases of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption etc. 9. individuals with orthostatic hypotension 10. individuals with severe hepatopathy 11. individuals who had taken alpha-1 blocker 12. individuals who had history of micturition syncope 13. individuals with nephropathy 14. elderly person 15. individuals who had taken pde5(phosphodiesterase-5) inhibitor 16. individuals who had taken cyp3a4 inhibitor 17. individuals who had taken antihypertensive drug(s)
increasing use of mental health services

Conditions: Major Depression

Summary: the purpose of this study is to test the effectiveness of open door (previously known as the treatment initiation program \[tip\]), a brief psychosocial intervention to address the psychological barriers to care and improve the use of mental health services by depressed community elderly. the intervention is designed to help the older adult identify the barriers, problem-solve to find solutions and mobilize the motivation to seek help. open door was developed to work collaboratively with an older adult who is depressed to improve access and adherence to mental health treatment.

the primary aim of this research study did not change from the original application; it is to conduct a randomized controlled trial of the effectiveness of a brief, psychosocial intervention on engagement in mental health care among homebound depressed older adults. engagement is defined as accepting a referral and attending a visit with a provider who could provide traditional mental health care (medication or psychotherapy). the intervention, now called open door, was developed to work collaboratively with an older adult who has depressive symptoms to address the barriers to care with the aim of helping them consider a referral and engage in mental health care. in prior research, this intervention has been found to improve treatment participation, reduce depressive symptoms and increase adherence to antidepressant therapy among depressed older adults in primary care and outpatient psychiatric settings. we propose that open door will improve the access to mental health care by reducing psychological barriers, providing education about care, and managing the resignation associated with the symptoms of depression among community dwelling depressed elders. additionally, we believe that despite the heterogeneity of mental health care that may be received, open door will be associated with reduced depressive symptoms by empowering the older adult to initiate care for him/herself.

Eligibility criteria:
inclusion criteria: * age 60 years and older * homebound * endorse depressive symptoms exclusion criteria: * presence of significant alcohol or substance abuse or psychotic disorder * high suicide risk, i.e. intent or plan to attempt suicide * cognitive impairment * inability to speak english * aphasia interfering with communication. * current use of antidepressants or psychotherapy

Keywords: geriatric depression
study to evaluate efficacy and safety of certolizumab pegol for induction of remission in patients with crohn's disease

Conditions: Crohn Disease

Summary: the primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe crohn's disease as compared with placebo based on crohn's disease activity index (cdai) score at week 6.


Eligibility criteria:
inclusion criteria: * male/female * 18 - 75 years inclusive * diagnosis of crohn's disease confirmed * moderate to severe disease activity (crohn's disease activity index (cdai) 225 - 450) * no previous treatment with anti-tumor necrosis factor (anti-tnf) medications exclusion criteria: * previous participation in a certolizumab pegol study * general exclusion criteria as common for studies in this indication

Keywords: cdp 870 certolizumab pegol cimzia ® crohn's disease induction clinical remission clinical response
askina calgitrol paste burns

Conditions: Third Degree Burns

Summary: the purpose of the study is to demonstrate that askina® calgitrol® paste is safe to use on iii degree burns by quantifying the concentration of silver in the blood during treatment and thus to show that the amount of silver absorbed will be no greater than those reported in the literature.


Eligibility criteria:
inclusion criteria: * adults (≥\>18 years age). no upper age limit * iii degree thermal burns from 2-30% tbsa as determined by the rule of nines * patients who underwent initial treatment within 24 hours after the injury at the latest * patients who underwent initial treatment directly at the burn centre of fnkv or the initial treatment was in accordance with the standard of care of the centre * all patients will have been hospitalised * patients who are capable of giving signing informed consent and have done so. exclusion criteria: * patients with electrical or chemical burns * patients with already infected wounds * patients taking systemic antibiotics on admission * patients pregnant or lactating * patients who fall into "vulnerable population" group with respect to informed consent or who are not capable of giving informed consent * patients who used or were treated with silver products for other reasons than treatment of the acute burn in the last 3 months * patients whose other burn wounds are being treated with silver products. * patients receiving renal dialysis * known allergy or sensitivity to any of the ingredients in askina® calgitrol® paste. * simultaneous participation in another interventional clinical trial
positive psychology to improve healthy behaviors after an acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: in this proof-of-concept study, the investigators will assess the ease and usefulness of a positive psychology program in patients with acute coronary syndrome and less-than-optimal adherence to health behaviors. the investigators believe that positive psychology (a field that studies boosting positive emotions rather than simply reducing negative emotions) will help this cardiac population to be more healthy. the investigators want to determine whether this positive psychology program has the potential to be an adjunctive treatment for cardiac populations.


Eligibility criteria:
inclusion criteria: * adult patients admitted to one of three cardiac inpatient units at massachusetts general hospital. * primary diagnosis of acute coronary syndrome (myocardial infarction or unstable angina). * less-than-optimal adherence to health behaviors. this will be defined as a mean score of less than 15 on the medical outcomes study specific adherence scale (scores range from 3-18, with higher scores indicating better adherence). exclusion criteria: * cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies. * patients not prescribed aspirin at discharge. * inability to communicate in english. * inability to participate in physical activity.

Keywords: acute coronary syndrome health behavior mental health
pharmacodynamics of injection of cisatracurium base on lean body mass pattern to maintain deep neuromuscular blockade in obese patients

Conditions: Obese Patients; Laparoscopic Colorectal Surgery

Summary: to observe the pharmacodynamics of intravenous injection of cisatracurium to maintain deep neuromuscular blockade in obese patients with lean body mass in laparoscopic colorectal surgery

according to the random number table method, one hundred and twenty patients who underwent elective laparoscopic colorectal surgery were divided into four groups (n=30): normal weight patients according to lean body weight group(nl group), normal weight patients according to real weight group (nr group), obese patients according to lean body weight group(ol group), and obese patients according to real weight group(or group).intraoperative deep neuromuscular blockade (ptc≤2)was maintained in all four groups.the dosage of cisatracurium, the number of injections,time to effect,time to recovery from tofr,time to recover tofr（train-of-four rate） to 0.7 and 0.9,and time to stay in pcau were recorded.the surgeon's satisfaction with the operative field and the average intraoperative pneumoperitoneum pressure were recorded at the time of pneumoperitoneum establishment,1 hour and 2 hours after pneumoperitoneum establishment.

Eligibility criteria:
inclusion criteria: * laparoscopic colorectal surgery * american society of anesthesiologists (asa) grades i-iii exclusion criteria: * patients with heart, lung and other vital organ disorders * preoperative fluid and electrolyte disturbance * preoperative water and electrolyte disorders have a history of neuromuscular disease or take medications that have an impact on neuromuscular function * there is a significant airway difficulty * refuse to sign informed consent

Keywords: laparoscopy cisatracurium obesity neuromuscular blockade pneumoperitoneum pharmacology
paclitaxel plus bevacizumab for older patients with breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer. furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.

elderly individuals make up a large part of the breast cancer population. older women are more likely than younger women to be diagnosed at a more advanced stage of breast cancer. however, when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. preference should be given to chemotherapeutic drugs with safer profiles regimens, such as weekly taxane, according to the siog recommendations. recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic breast adenocarcinoma * no previous therapy (other than hormonal therapy) for metastatic disease is accepted * measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * performance status (who) 0-2 * adequate liver (serum bilirubin \<1.5 times the upper normal limit, ast and alt \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases) * adequate renal function (serum creatinine \<1.5 times the upper normal limit) * bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) * no radiation of measurable disease (except brain metastases) * no progressive brain metastases according to clinical or radiological criteria * no brain metastases without prior radiation therapy * written informed consent exclusion criteria: * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * history of stroke * anticoagulation therapy (except of low dose aspirin \<325mg) * other invasive malignancy except non-melanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women

Keywords: breast cancer elderly chemotherapy anti-angiogenesis therapy
a novel functional imaging technique with flt-pet/mri for staging, response assessment and radiation treatment planning in cervix cancer

Conditions: Image, Body; Cervix Cancer

Summary: this pilot study aims to monitor early tumour response based on \[18f\]flt-pet/mri scans and to determine the feasibility of personalised radiotherapy to spare active bone marrow areas identified by \[18f\]flt-pet/mri. bone marrow within the pelvis will be outlined by employing 18flt pet to identify active bm within bony structures. subsequently, treatment plans with various conformal radiotherapy techniques will be generated with different optimization approaches toward bone marrow while ensuring adequate tumor coverage. dosimetric comparison amongst plans will be carried out.


Eligibility criteria:
inclusion criteria: * have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice * histologically or cytologically confirmed cervical carcinoma * figo staged ib to iva * underwent mri pelvis * underwent fdg-pet/ct or mri abdomen or ct thorax and abdomen or chest x ray for routine staging * planned for radical radiotherapy with or without chemotherapy * no distant metastasis in staging work up * ecog 0-2 * age 21 or over (no upper age limit) exclusion criteria: * patients scheduled for neoadjuvant chemotherapy * patients with previous hysterectomy or radiotherapy to the pelvis * patients who are pregnant or lactating * patients who do not meet the above mentioned inclusion criteria * patients who refuse to give and/or sign the informed consent * patients who currently have a pacemaker * patients who have a history of serious adverse events related to a previous mri or pet/ct * patients who are unable to undergo mri scanning * patients with a known allergy against any component of the contrast enhancing agent * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the trial.

Keywords: pet/mri imaging technique cervix cancer flt pet radiotracer response assessment radiation treatment
reduction of pain in colonoscopy - loop first versus last

Conditions: Pain

Summary: colonoscopy is an endoscopic examination of the colon. colonoscopy is used to investigate medical gastroenterological diseases, as well as to investigate suspected cancer and to prevent it by identifying and removing premalignant changes - polyps (e.g., as part of the national screening program for colorectal cancer). as part of a normal endoscopic examination, the tip of the endoscope is bent (retroflexed) to look "backward" into the rectum. this is done to better see the inside of the rectal opening. performing such a retroflexion of the scope is often associated with discomfort/pain for the patient. it takes 5-10 seconds. there are no guidelines on when such a retroflexion should be done - at the beginning or at the end of the procedure. the aim is to investigate whether the timing of retroflexion makes a difference in the recollection of pain following the procedure. in this way, the pain of colonoscopy might be reduced in the future simply by changing the timing of the retroflexion. the study is solely about performing this retroflexion either at the beginning or at the end of the examination. nothing is changed in the diagnostic part of the examination. the background of the study is a study from 2003 that shows that taking about a one-minute pause in the rectum at the end of the colonoscopy can reduce the overall pain perception of the examination. this was shown without changing the pain during the procedure and despite the fact that the examination itself was prolonged due to the intervention. this relationship is explained by studies showing that the pain experience at the end of a procedure has a greater influence than the pain experience at the beginning of a procedure on the overall pain experience. hypothesis: by retroflexing in the rectum first during a colonoscopy versus at the end, patients will perceive the overall procedure as less painful.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective diagnostic colonoscopy at the surgical department exclusion criteria: * age \<18 * pregnancy * colonoscopy under general anæsthesia * patients not fluent in danish * patients uanable to understand the study (e.g. people with diagnosed or suspected dementia)
a new scoring system for perineural and vascular invasion in pancreatic cancer

Conditions: Pancreas Cancer

Summary: the aim of this study is to validate both retrospectively and prospectively a newly proposed scoring system for perineural and vascular invasion in pancreatic ductal cancer and correlate it with disease free survival, early recurrence, site of recurrence, overall survival and neoadjuvant treatment.

perineural invasion (pni) is defined as the presence of cancer cells along nerves and/or within the epineural, perineural and endoneural spaces of the neuronal sheath.clinically, pni is associated with increased tumor recurrence, poor survival after pancreatectomy and pain, an invalidating symptom that may impair quality of life. pancreatic ductal adenocarcinoma has one of the highest incidences of pni (70-100%) among all types of cancer, which correlates with a poor prognosis and decreased survival. pni is a still not uniformly characterized or quantified event, usually it is described only dichotomously ("present" or "absent"), despite some efforts to use a more detailed scoring system. however, these scores are not specifically developed for pancreatic surgical specimen. vascular invasion (vi), which is assumed to be associated with a more aggressive tumor biology and dissemination, lacks a specific scoring system as well. the primary aim of this study is to validate both retrospectively and prospectively a novel pni and vi scoring system aimed at a more detailed stratification of perineural invasion, together with an accompanying scoring system for vascular invasion, and correlated them with disease free survival (dfs).

Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients undergoing all types of pancreatic resection (pancreatoduodenectomy, left pancreatectomy, total pancreatectomy, both laparotomic and laparoscopic). * proven pancreatic ductal adenocarcinoma (cytology or biopsy). * patients that received neoadjuvant therapy (ct +/- rt) can be included. * patients able to sign the informed consent. exclusion criteria: * age \< 18 years. * patients with other ongoing oncological diseases.

Keywords: neural invasion vascular invasion
pilot study of intra-arterial cisplatin with iv thiosulfate in patients with lung cancer or lung metastases

Conditions: Lung Neoplasms; Neoplasm Metastasis

Summary: this phase i study proposes the use of systemic thiosulfate rescue to allow supradose intra-arterial cisplatin delivery to lung tumors. eligible patients would be those with at least one lung lesion large enough of characterize angiographically. all patients will first undergo a ct arteriogram of the target tumor. patients will then receive 2 treatments on 2 consecutive weeks. the primary endpoint will be toxicity, with secondary endpoint of response as measured on week 4. this pilot study will also determine how technically feasible it is to locate the blood supply to these tumors and deliver cisplatin. if the first 6 patients do well, 6 additional patients will be accrued for a total of 12.


Eligibility criteria:
inclusion criteria: * primary lung cancer (any type) or dominant lung metastases from other primary cancers. * patients must have either measurable or evaluable disease. * karnofsky performance status ≥ 70%. * greater than 18 years of age. * life expectancy \> 3 months. * 3 week elapse from previous cytotoxic therapy (except for erlotinib or hormonal therapy, which can be ongoing) with side effects improved to grade 2 or less, and no prior radiotherapy to the lung. * adequate organ function. * treated brain metastases, if present, with toxicities improved to grade 2 or less. * willingness and ability to sign a written informed consent. exclusion criteria: * prior radiation to the largest lesion in the lung. * current pregnancy or breast-feeding. * unwillingness or inability to practice contraception. * renal insufficiency. * comorbidities of grade 3 or greater. * concurrent medical or psychiatric conditions as defined by the treating physician which would preclude safe performance of study procedures or compromise the ability of the patient to consent to study.

Keywords: lung cancer non-small cell lung cancer small-cell lung cancer lung metastases metastatic cancer stage iiia stage iiib stage iii stage 3
uterine artery pulsatility index and materno fetal outcomes

Conditions: Labor Complication

Summary: high uterine artery index pulsatility (pi) is associated with small for gestationnal age but also with stillbirth and distress during labor.

measures of uterine artery pi is made with transabdominal color flow during labor. the right and left uterine arteries are visualized at the crossover wth the external iliac arteries. pi is measured and the mean pi of the two vessels is calculated and expressed as multiple of the median (mom).the outcomes stillbirth, distress and vaginal or cesarean delivery, apgar sore \<7 at 5 minutes, birth weight and maternal outcomes: preeclampsia, hemorrhage and other complications are noted.

Eligibility criteria:
inclusion criteria: * gestationnal age \>=34 weeks * during labor exclusion criteria: * elective cesarean even if labor * non elligible ultrasound criteria of good measurement of uterine artery pi

Keywords: stillbirth hemorrhage